FULL PRESCRIBING INFORMATION

A MANAGEABLE SAFETY PROFILE

The most common side effects of PROVENGE are generally mild to moderate and well tolerated

Most infusion-related side effects lasted 1 or 2 days.

There are potential risks associated with PROVENGE:

•
In controlled clinical trials, 71.2% of men in the PROVENGE group developed an acute infusion reaction
—
The most common side effects (≥20%) were chills, fever, and fatigue. In 95.1% of patients reporting acute infusion reactions, the reactions were mild or moderate. Fevers and chills generally resolved within 2 days (71.9% and 89%, respectively)
•
1.5% of men discontinued their treatment with PROVENGE due to adverse events
•
Some patients have experienced serious adverse events while taking PROVENGE. See Important Safety Information for more details.

MOST COMMON ADVERSE EVENTS (≥15%) REPORTED IN THE PROVENGE GROUP 1,a

Adverse events

Chills Fatigue Fevers Back pain Nausea Joint ache Headache
PROVENGE
(n=601)		 53.1 41.1 31.3 29.6 21.5 19.6 18.1
Control
(n=303)		 10.9 34.7 9.6 28.7 14.9 20.5 6.6

*All grades reported in ≥15% of patients randomized to PROVENGE; the safety analysis is based on 601 patients with prostate cancer in the PROVENGE group who underwent at least 1 leukapheresis procedure in Phase 3 clinical trials.1

•
Most common acute infusion reactions (≥20%) were chills, fever, and fatigue1
•
95.1% of acute infusion reactions were mild or moderate in severity1
IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Full Prescribing Information.

Adverse events experienced by patients receiving PROVENGE can generally be managed in the outpatient setting. PROVENGE does not require dosage adjustments, monitoring of liver/kidney functions, or concomitant steroids.

SEE PROVENGE SURVIVAL DATA >>
PROVENGE side effects
    Reference:
  1. PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.
INDICATION

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Full Prescribing Information.